4729-5-35
Automated drug delivery systems.

(A)
All
automated drug delivery systems intended for use by a terminal distributor of
dangerous drugs to assist in the dispensing of a drug pursuant to rules
4729-5-01 and
4729-17-01 of the Administrative
Code must meet the following requirements:

(1)
Each automated drug delivery system must be
approved via the procedure established in paragraph (B)
of this rule by the board of pharmacy prior to its implementation by the
terminal distributor of dangerous drugs;

(2)
The automated drug
delivery system shall have a documented and ongoing quality assurance program
that monitors total system performance and includes
security measures to ensure the safe and effective distribution of drugs;

(3)
The automated drug delivery system shall have
adequate security to prevent unauthorized individuals from accessing or
obtaining dangerous drugs and includes safegaurds to
detect diversion of dangerous drugs;

(4)
The records kept by the automated drug delivery
system shall comply with all board requirements.

(B)
Prior to the
approval of an automated drug delivery system, the board shall receive a
request from the responsible person on the terminal distributor of dangerous
drugs license. Upon notification, the board shall conduct an inspection of the
system to determine if it meets the requirements in paragraph (A) of this
rule.

(C)
If an inspection does not result in the approval of an
automated drug delivery system, the responsible person named on the terminal
distributor of dangerous drugs may request an in-person meeting with the board
to appeal the denial.